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Humanwell Healthcare’s Recombinant Plasmid Hepatocyte Growth Factor Injection Accepted for NMPA Review
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that the National Medical Products Administration (NMPA) has accepted a market filing for review of its Category 1 therapeutic biologic product, the recombinant plasmid hepatocyte growth factor injection. This development signifies a step forward in the potential approval process for…
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Haisco Pharmaceutical’s HSK46575 Receives NMPA Approval for Prostate Cancer Clinical Trial
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced the receipt of clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK46575, which is intended for the treatment of prostate cancer. HSK46575: A Promising Oral Small Molecule InhibitorHSK46575 has demonstrated significant therapeutic…
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Sichuan Kelun-Biotech’s SKB500 Receives NMPA Clinical Clearance for Solid Tumor Treatment
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd, (HKG: 6990), a leading biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its novel drug candidate, SKB500. This development marks a significant step forward in the advancement of the company’s pipeline. SKB500:…
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Cinclus Pharma’s Linaprazan for GERD Receives NMPA Marketing Approval
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Sweden-based Cinclus Pharma has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug candidate, linaprazan, which is indicated for the treatment of gastroesophageal reflux disease (GERD). The drug is expected to be commercialized in China in 2025, marking a significant milestone for…
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Shanghai Henlius Biotech’s HLX11 Biosimilar Accepted for Review by China’s CDE
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Shanghai Henlius Biotech Inc. (HKG: 2696), a leading biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a market filing for its HLX11, a biosimilar version of Perjeta (pertuzumab). The company is seeking regulatory approval for…
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Shanghai Henlius Biotech’s HLX22 Receives NMPA Approval for Phase II HER2-Targeted Study
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its HER2-targeted monoclonal antibody (mAb), HLX22, in-licensed from AbClon, Inc. The drug is set to be tested in a Phase…
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GSK plc Enters Exclusive Option Agreement with Duality Biologics for ADC Candidate DB-1324
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UK-based GSK plc (NYSE: GSK) has entered into an exclusive option agreement with Duality Biologics, a developer of antibody conjugate drugs (ADCs) with operations in the United States and China. The agreement is in relation to a potentially best-in-class ADC candidate, DB-1324. Terms of the Agreement and Financial DetailsUnder the…
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Guangzhou Virotech’s Oncolytic Virus M1 Receives Tacit Clinical Approval from NMPA
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Guangzhou Virotech Pharmaceutical Co., Ltd., a China-based pharmaceutical company, has announced receiving tacit clinical approval from the National Medical Products Administration (NMPA) for its oncolytic virus therapy, M1 (VRT106). This approval paves the way for an imminent Phase I clinical study in China, which will assess the safety, tolerability, pharmacokinetics,…
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Ipsen Secures Global Licensing Agreement for Biomunex Pharmaceuticals’ BMX-502 T Cell Engager
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France-based Ipsen (OTCMKTS: IPSEY) has announced a significant global licensing agreement with compatriot firm Biomunex Pharmaceuticals concerning the latter’s T cell engager (TCE), BMX-502. Ipsen is poised to secure exclusive development, manufacturing, and commercialization rights for BMX-502 across global territories. Responsibilities and Milestones Under the AgreementUnder the terms of the…
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OncoC4, Inc. Receives FDA Clearance for AI-081, a PD-1 and VEGF Bispecific Antibody
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US-based OncoC4, Inc. has announced that it has received clinical clearance from the US Food and Drug Administration (FDA) for its innovative bispecific antibody, AI-081, which targets both PD-1 and VEGF pathways. Composition and Mechanism of AI-081AI-081 is composed of proprietary high-affinity clinical-stage anti-PD-1 (AI-025) and anti-VEGF (AI-011) antibodies. This…
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Luye Pharma’s Zepzelca Receives NMPA Approval for Metastatic Small Cell Lung Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Zepzelca (lurbinectedin) with priority review status. This approval allows the use of Zepzelca to treat adult patients with metastatic small cell lung cancer (SCLC) who are…
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Sacituzumab Tirumotecan Earns FDA Breakthrough Therapy Designation for EGFR Mutated NSCLC
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Sacituzumab tirumotecan (SKB264/MK-2870), a TROP2-targeted antibody drug conjugate (ADC) co-developed by Merck, Sharp & Dohme (MSD, NYSE: MRK) and Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has been granted a breakthrough therapy designation (BTD) by the US FDA. This designation is for the treatment of non-small cell lung cancer (NSCLC)…
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Merck’s Recarbrio Approved by NMPA for Hospital-Acquired Infections and Complicated UTIs
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US pharmaceutical major Merck, Sharp & Dohme Inc., (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its combination antibacterial drug, Recarbrio (imipenem, cilastatin, and relebactam). This new treatment is indicated for patients aged 18 years and older with hospital-acquired…
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Abbisko Therapeutics Gets FDA Green Light for Phase I Study of ABSK131 Inhibitor
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Shanghai-based biotech company Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I study for its small molecule inhibitor, ABSK131. This investigational drug targets PRMT5 and MTA in patients with advanced solid tumors that…
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Hefan Medicine’s Piracetam Production and Marketing Suspended Over GMP Violations
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The National Drug Alliance Procurement Office has issued a notification to suspend the manufacturing and marketing of piracetam by Zhuhai Hefan Medicine Co., Ltd. The suspension comes as a result of severe defects found in the company’s manufacturing management process, which are in direct violation of the Good Manufacturing Practice…
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InventisBio’s Oral TYK2 Inhibitor D-2570 Achieves Positive Results in Phase II Psoriasis Study
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China-based InventisBio (Shanghai) Co., Ltd (SHA: 688382) has announced the successful completion of a Phase II study for its oral TYK2 inhibitor, D-2570, in the treatment of psoriasis, with positive outcomes. Understanding Psoriasis and the Role of TYK2 InhibitionPsoriasis is an immune-mediated chronic disease characterized by recurrent, inflammatory, and systemic…
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Shanghai Henlius Biotech’s Serplulimab Approved for First-Line nsNSCLC Treatment in China
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Shanghai Henlius Biotech Inc., (HKG: 2696) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10), marking its fifth indication approval in China. The drug can now be used in combination with pemetrexed and carboplatin as…
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Zhejiang Huahai Pharmaceutical Initiates Clinical Study for HB0056 in New Zealand
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Zhejiang Huahai Pharmaceutical Co., Ltd. (SHA: 600521), through its subsidiary Shanghai Huaota Biopharmaceutical Co., Ltd., has announced the first subject dosing in a clinical study for its potential first-in-class drug, HB0056, in New Zealand. This marks a significant step forward in the development of this innovative therapy. HB0056: A Bispecific…
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HutchMed and Innovent Biologics’ Fruzaqla-Tyvyt Combo Gets NMPA Conditional Approval for Endometrial Cancer
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Chinese firms HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) and Innovent Biologics, Inc. (HKG: 1801) have jointly announced that they have received conditional approval from the National Medical Products Administration (NMPA) for the combination of Fruzaqla (fruquintinib) and Tyvyt (sintilimab). This treatment is intended for patients with advanced endometrial cancer…
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AccurEdit Therapeutics’ ART001 Shows Over 90% TTR Reduction in ATTR Amyloidosis Trial
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Suzhou-based gene editing specialist AccurEdit Therapeutics has announced positive results from an ongoing investigator-initiated trial (ITT) for its in vivo gene editing product, ART001. This lipid nanoparticle (LNP) delivered treatment is designed for transthyretin amyloidosis (ATTR), a rare, progressive, and fatal disease. In subjects who completed at least 48 weeks…
